BILL ANALYSIS
Senate Appropriations Committee Fiscal Summary
Senator Christine Kehoe, Chair
341 (DeSaulnier)
Hearing Date: 5/26/2009 Amended: 5/14/2009
Consultant: Katie Johnson Policy Vote: Health 6-3
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BILL SUMMARY: SB 341 would require the California Department of
Public Health (CDPH) to make every effort to enter into a
contract with the University of California (UC) to establish a
program to evaluate scientific literature related to the safety
and effectiveness of prescription drugs and to communicate that
information to consumers and prescribers.
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Fiscal Impact (in thousands)
Major Provisions 2009-10 2010-11 2011-12 Fund
UC Internet Web site, $1,000 $2,000 $2,000Federal/
determination of drug classes, Private
clinical advisory board
UC prescriber pilot program $75 $150 Federal/
Private
CDPH contract management, $800 $700
$700Federal/
regulations, and report requirement Private
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STAFF COMMENTS: This bill meets the criteria for referral to
the Suspense File.
Existing federal law establishes the United States Food and Drug
Administration (FDA) within the Department of Health and Human
Services to regulate the manufacture, labeling, sale, and
distribution of drugs. Existing federal law also requires the
FDA to ensure that prescription drug information is truthful and
accurately communicated to the public.
Existing state law, the Sherman Food, Drug, and Cosmetic Law,
regulates the packaging, labeling, and advertising of food,
drugs, and cosmetics under the CDPH.
This bill would require the CDPH to make every effort to enter
into an agreement with the UC to establish a program to evaluate
the safety and effectiveness of prescription drugs in
California. This bill would require the UC to determine the
classes of prescription drugs for the purposes of these
provisions and would exempt drugs used to treat mental illness
unless those drugs are used to treat additional conditions.
This bill would require the program to establish a clinical
advisory panel to serve as advisors to the program.
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SB 341 (DeSaulnier)
This bill would require that the program include an Internet Web
site that would report information on the safety and
effectiveness of brand name and generic drugs to health care
professionals and consumers in a culturally competent manner.
The information presented on the Web site would address the
differential impact of medications within a drug class based on
gender, age, race, and ethnicity, among other factors, and could
include links to other relevant Web-based information if that
information was approved by the UC.
This bill would require that the UC, in consultation with the
advisory board, rely on the best available scientific
information. When compiling scientific evidence, this bill would
require the program to operate transparently, as specified, to
consider good quality peer-reviewed clinical trials and studies,
as specified, have the evidence reviewed by qualified
specialists, and report any identified gaps in research and
opportunities to improve on current research. This bill would
require that the program provide a 30-day comment period, during
which stakeholders may offer feedback, which would be followed
by a revision period before the posting of final reviews on the
Web site.
This bill would require the program to begin reporting on the
safety and effectiveness of prescription drugs on a date certain
that would be specified in the CDPH/UC contract. This bill would
state that it would be the intent of the Legislature that the
reporting begin as soon as possible. This bill would require the
program to develop and implement conflict-of-interest policies
that would be at least as rigorous as those utilized by the
California Health Benefits Review Program (CHBRP).
This bill would require the program to include a prescription
education service to provide health care professionals with
information and education on the comparative efficacy, safety,
and cost-effectiveness of prescription drugs and on the use of
the Web site as a pilot project for health care professionals
associated with state-funded health care programs in Contra
Costa County until January 1, 2015. This bill would require the
CDPH to determine a second county in which the pilot project
would also be available until January 1, 2015. The prescription
education service would provide for clinician educators that
would conduct in-person outreach and education sessions on a
one-to-one basis with health care professionals. Such a pilot
project could cost about $150,000 annually. If the pilot project
were implemented statewide in 50 counties, it could cost
approximately $3.75 million each year.
It would likely cost the UC approximately $2 million to support
ongoing administrative services, faculty and research staff,
content experts, the advisory panel, reporting of the program's
methodology and processes, and Web site development and
maintenance, among other expenses.
This bill would require the CDPH to adopt regulations by January
1, 2011, that would establish the minimum clinical and education
qualifications, required training, and a code of conduct for the
educators of the pilot program.
To implement this bill, the CDPH would need approximately
$800,000 in FY 2009-2010 and $700,000 ongoing to maintain at
least 5 staff to promulgate regulations, manage
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SB 341 (DeSaulnier)
the contract with the UC, administer the pilot program, and
maintain the website, among other duties.
This bill would require the CDPH by December 1, 2011, and every
year thereafter until December 1, 2015, to present to the
Assembly and Senate Committees on Health a report on the
development of the prescription education service pilot program.
This bill would provide that these provisions would be
implemented only with federal and/or private funds and only to
the extent that the UC would determine that it would not be
substantially similar to any other federally funded program. At
the writing of this analysis, neither federal nor private
funding sources had been identified to support the
implementation of the provisions in this bill. This program
would appear to duplicate education efforts on the safety and
efficacy of prescription drugs by several public, private
industry, and consumer entities.
The American Recovery and Reinvestment Act of 2009 provides for
$1.1 billion for comparative effectiveness research and is
intended for the following federal entities: $300 million for
the Agency for Health Quality Research, $400 million for the
National Institutes of Health, and $400 million for the
Secretary of Health and Human Services. It appears that some of
these funds would be available to entities for a limited time
period on a competitive basis to conduct comparative
effectiveness research. Although it is possible that the UC or
the CDPH could apply for those funds, they would not be
available to sustain this program on an ongoing basis.
This bill is substantially similar to AB 71 (Chan) of 2006,
which died on the Senate Floor. A key difference is that AB 71
contained a fee on manufacturers of drugs sold in California to
provide revenues to support the provisions of the bill. A
similar provision was removed from this bill, SB 341, following
its Senate Health Committee hearing on April 29, 2009.